A key tenet of safety within pharmacy is the application of multiple safeguards to support high-risk processes and procedures. Similarly, when safeguarding against parenteral nutrition (PN) errors it is necessary to use a multifaceted approach. UNC Medical Center prioritizes patient safety when insourcing PN products (see the SIDEBAR) by leveraging a combination of automation, policies, and training to ensure that each product is prepared and administered as safely as possible. A strong PN program must rely on multiple strategies to ensure safety throughout the process.

Mitigating PN Risks

UNC Medical Center offers one PN option (2-in-1) and provides lipids separately if needed. This decision was largely driven by the desire to compound specialized PN for patients as opposed to utilizing a multichamber bag PN formulation. Nevertheless, all PN products are associated with numerous safety concerns, including the risk of:

• Central line infection (associated with poor line care, not inherently the PN itself)
• Electrolyte abnormalities
• Hyperglycemia
• Overfeeding
• Volume overload
• Hepatoxicity (more common in long-term PN)
• Metabolic bone disease (more common in long-term PN)
• Cholestasis (more common in infants)
• Extravasation/infiltration (risk with peripheral PN)
• Central line malpositioning

The risk of errors spans the entire medication use process, including prescribing incorrect ingredients or omitting necessary components from the PN mixture. Notably, transcription errors are the primary risk during order review and verification. Administration errors are also a risk, specifically the peripheral administration of a centrally formulated PN.

Several strategies can be leveraged to prevent patient harm in the PN-use process. These include maximizing the use of technology, utilizing trained personnel in all phases of the PN use process (ie, prescribing, order review and verification, compounding, administration), minimizing handwritten or verbal orders, and creating initial as well as annual competencies for all personnel involved in the PN use process. The American Society for Parenteral and Enteral Nutrition (ASPEN) is the premier source for PN-related safety references and can support the development of these safeguards.1

Utilize Technology

Help minimize compounding errors that occur during preparation by using an automated compounding device and reducing the number of manual additions to the PN product. Our institution worked toward eliminating errors by creating a direct user interface between the EMR and the automated compounding device.

During the prescribing step of the PN use process, implementing clinical decision support tools can prevent errors from reaching the patient. For example, concentration minimums and maximums can help prevent compatibility and stability errors. Individual ingredients are prescribed within standard typical ranges, but atypical patients may require amounts higher (or lower) than standard doses. Soft limits can be set to warn the verifying pharmacist that the dose is atypical. Catastrophic limits can be set as hard stops to prevent any transcription errors during the order entry phase that could result in patient overdoses. These same limits carry over when administering PN via a smart pump, and both soft lower limits and hard upper limits can be utilized in adult and pediatric patient populations. Additionally, PN orders in the EMR can be prepopulated with standard doses to help guide the ordering provider.

As we refine these processes at UNC Medical Center, we rely on a comprehensive medication safety program utilizing just culture for error reporting. We seek system solutions (ie, utilizing smart pumps or EMR optimization) to prevent future errors and optimize our current practice.

Incorporate Standardization

Another strategy to help mitigate the potential for errors is standardization. Efforts should be made to standardize the ingredients available for inclusion in PN, the order in which ingredients appear on the order, and the units in which ingredients are ordered. Standardization is important whether an EMR or paper orders are used. ASPEN has published recommendations for standardized order templates for neonatal and adult populations.1

Engage providers early in the decision-making process to gain buy-in when standardizing PN processes. It is important to ensure that providers have the opportunity to provide feedback and ultimately endorse the chosen approach. Their concerns should be heard and addressed before making any changes to PN procedures. Key to this process is communicating the reasoning behind standardization and addressing any safety concerns related to the change. Any changes should reflect evidence-based medicine to ensure providers are supportive of the reasoning behind both clinical and operational changes.

Peripheral PN

In additional to general standardized policies, establish clear P&Ps for the use of central and peripheral PN formulations coupled with staff education. Peripheral PN is most common in pediatric and neonatal patients, but evidence supports safe use in adults as well. Osmolarity limits should be established for each age group. These limits may further differ among types of peripheral access and the specific venous location. Peripheral PN is acceptable for central administration, but centrally formulated PN is not safe for peripheral administration. Centrally formulated PN should be clearly marked for central line administration only using auxiliary labels or label comments to ensure it is apparent prior to administration. Venous access is an essential component of the PN order, and EMR technology may allow incorporation of institutional osmolarity limits based on the access indicated.

Develop Competencies

Once a strong PN program is in place, institution-specific competencies, both at the point of initial onboarding and via annual assessment, are critical to ensure continuous safe PN use. These competencies should be tailored to each department involved in the PN use process, from pharmacy to nursing. Also consider board certification via available certifications such as nutrition support and compounded sterile preparations. If board certification is not an option for your team, consider alternative education and certificate courses where available.

Shortage Management

A potential challenge when compounding PN products in-house is the frequency of drug shortages. Over the last few years as drug and component shortages have increased, so have the complexities of what can be added to the automated compounding device and what must be manually added after a bag is pumped. Each manual ingredient addition introduces another entry into the bag and a risk for compromising the sterility of that compound. Manual additions are difficult to track beyond simply writing the ingredients on the compounding record, a practice that can lead to transcribing errors. Additionally, ensuring that staff are adequately trained and understand the automated compounding device operation is a safety concern for insourcing. Given the complexity of these devices, ensure they are operated only by trained personnel.

Proactive planning and communication are crucial for managing drug shortages that impact PN. Response plans should be multidisciplinary and involve all stakeholders in the PN use process. A proactive approach avoids stockpiling any PN components and instead focuses on rationing the medications as equitably as possible. Alternate supply sources should be explored during this time to provide increased sourcing opportunities. Larger health systems may consider developing a streamlined approach across all entities to maximize resources. ASPEN also provides direction for developing drug shortage management plans.1

Outsourcing

While our facility does not currently outsource any PN products, there are occasions, such as during drug shortages, when outsourcing becomes crucial. Outsourcing offers a variety of operational benefits, especially when facilities are short staffed or lack the training required to operate an automated compounding device. This approach is also beneficial when specialty compounds are needed (such as a branched-chain-amino-acid-free PN, which is not commercially available).

When selecting a 503B or 503A outsourcing vendor, it is critical to thoroughly vet and evaluate organizations under consideration before making the final commitment to outsourcing. The overriding safety concern is sterility, thus ensuring any outsourced product is produced in an acceptable environment is our paramount concern. Outsourcing removes the facility’s control over the compounding process and each facility should consider that risk when reviewing candidates. Another issue for facilities utilizing outsourced vendors to consider is the inherent risk that the outsourced 503A facility could cease compounding, thus creating the need to operationalize insourcing immediately. Additionally, some outsourcing facilities require transcribing the PN into their ordering system, which increases the potential for transcription errors.

Looking Ahead

Our future goals for ensuring safe PN use span all aspects of the PN use process. With the goal of continuing to refine our shortage management process, particularly for PN components, we are considering routing shortage management through a central committee to utilize systemwide inventory and standarize shortage management strategies.

To enhance our current training program and competency evaluations for PN, we will create a more tailored training program for technicians with the goal of optimizing frontline staff involvement. Additionally, we plan to expand education on PN compounding practices for the PN clinical team. This will allow us to leverage the safety advantages that result when the clinical and operational teams understand each other’s workflows.

Conclusion

PN safety necessitates a rigorous set of policies and procedures that target risk opportunities throughout the process. The policies and procedures should span multiple departments and include plans to address shortages, either internally or via outsourcing. The overall plan should anticipate where errors can occur and rely on a variety of techniques to move through the process safely and efficiently, while providing sufficient flexibility to grow as new opportunities present.

Reference

1. American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Resources. https://www.nutritioncare.org/pnresources/. Accessed February 26, 2024.

Felicia R. Britt, PharmD, MS, BCPS, is the clinical manager for compounding and perioperative pharmacy services at the UNC Medical Center. Felicia earned her doctor of pharmacy degree from the UNC Eshelman School of pharmacy and completed a combined PGY1/PGY2 residency in health system pharmacy administration and leadership at Massachusetts General Hospital.

Emily Lineberry, PharmD, MS, BCPS, is the assistant director of acute and ambulatory care clinical services at UNC Medical Center. Emily earned her doctor of pharmacy from the University of North Carolina Eshelman School of Pharmacy and completed a combined PGY1/PGY2 residency in health-system pharmacy administration at The Ohio State University Wexner Medical Center.

Sara Bliss, BCPS, BCNSP, BCCCP, FASPEN, is a clinical pharmacist practicing in nutrition support and trauma at the University of North Carolina Hospitals in Chapel Hill, North Carolina. Sara graduated from the University of Tennessee Health Science Center with her PharmD in 2010. After graduation, she completed a PGY1 pharmacy practice residency and a PGY2 nutrition support pharmacy residency at the University of Arizona Medical Center.

SIDEBAR

UNC Medical Center’s PN Program

UNC Medical Center has more than 900 beds and is part of a statewide health system. We are a tertiary care facility, academic medical center, and level 1 trauma center that primarily functions using a decentralized distribution model with automated dispensing cabinets across the institution. On average, we compound 1,200 PNs per month across both adult and pediatric patients.

UNC Medical Center uses an automated compounding device for PN preparation. Through our electronic medical record (EMR) we utilize clinical decision support. This includes, but is not limited to, soft and hard limits for individual PN ingredients, osmolarity based on PN route, and dose or drug interaction warnings. We also utilize an interface between our EMR and the automated compounding device to help reduce errors with order transcription. Our institution requires staff to enter and verify all adult PN orders by 1500. This cut-off time is in place daily to ensure the product can be prepared safely and delivered in time for administration at midnight.